G43
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Diagnosed migraine (episodic migraine with/without aura or chronic migraine) according to criteria 1.1, 1.2, 1.3 of the International Classification of Headache Disorders (ICHD-3, 3rd Edition, 2018, Headache Classification Committee of the International Headache Society, IHS). • Current treatment at the Migraine and Headache Clinic Königstein. • Duration of disease of at least 12 months.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale sum of each the Migraine Interictal Burden Scale (MIBS-4, German version, Buse et al., 2007) and the Cogniphobia Scale for Headache Disorders (CS-HD, German version, Klan et al., 2024) | — |
Secondary
| Measure | Time frame |
|---|---|
| • To determine convergent validity, the values of the following established questionnaires are recorded: (i) Headache Impact Test (HIT-6™, Gandek et al., 2003, Kosinski et al., 2003), (ii) Depression, Anxiety and Stress Scales (DASS, Nilges & Essau, 2015), (iii) short form of the Headache Triggers Sensitivity and Avoidance Questionnaire (HTSAQ-SF-G, Caroli et al, 2020), (iv) short form of the Headache Management and Self-Efficacy Scale (HMSE-G-SF, Graef et al., 2015), (v) Fear of Attacks in Migraine Inventory (FAMI, Klan et al., 2022). • As a further approach to determine the convergent validity, the following clinical parameters are collected: (i) migraine days in the past four weeks, (ii) days with acute migraine medication in the past four weeks. • To determine divergent validity, the openness scale of the NEO Five Factor Inventory (NEO-FFI-30, German 30-item short form, Körner et al., 2015) is recorded. • To determine the criterion-based sensitivity to change, the subjective improvement experienced by the patients is recorded (numerical rating scale 1 to 7, with 1 = strong deterioration, 2 = medium deterioration, 3 = slight deterioration, 4 = no change, 5 = slight improvement, 6 = medium improvement, 7 = strong improvement). • To establish an empirical cut-off value, a comparison with self-reported disability is intended (based on the scale for clinical assessments and diagnoses of the Diagnostic Interview in Psychological Disorders [DIPS Open Access 1.2, Margraf et al., 2021], a scale value = 4 is defined as clinically relevant disability). | — |
Countries
Germany
Contacts
Psychologisches Institut der Johannes Gutenberg-Universität Mainz